Effectiveness of Nutritional Program Among Diabetic Patients
Primary Purpose
Dyslipidemia Associated With Type II Diabetes Mellitus
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
DASH diet
Sponsored by
About this trial
This is an interventional treatment trial for Dyslipidemia Associated With Type II Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- 1-clinical diagosis of type2diabetes 2-clinical diagnosis of hyperlpidemia 3-must be helpful patient 4-age below 70year
Exclusion Criteria:
1-insulin dependant diabetes 2- pregnancy 3-heart disease 4- renal disease. 5-pregnancy
-
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
group of intervention will receive nutritional program
group of control will not receive nutritional program
Arm Description
group of type 2 diabetes on diabetic diet undergo nutritional program (low fat contents) to control the lipid profile (lowering cholesterol profile) in duration of 3 months.
group of type 2 diabetes on diabetic drugs without nutritional program to compare their lipid profile with the diabetic patients on nutritional program.
Outcomes
Primary Outcome Measures
Evaluate the effectiveness of one of the most common dietary approches;DASH diet in controlling lipid profile in diabetic patients.
number of type 2 diabetic patients will undergo nutritional program to control their lipid profile to improve the insulin sensitivity and follow up the result of the diet by investigations (lipid profile) in duration 3 months .
Secondary Outcome Measures
Full Information
NCT ID
NCT05128747
First Posted
September 15, 2021
Last Updated
November 17, 2021
Sponsor
Assiut University
1. Study Identification
Unique Protocol Identification Number
NCT05128747
Brief Title
Effectiveness of Nutritional Program Among Diabetic Patients
Official Title
Effectiveness of Nutritional Program Intervention for Control of Lipid Profile Among Diabetic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 1, 2022 (Anticipated)
Primary Completion Date
October 1, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Dyslipidemia is very common in type 2 diabetes mellitus affecting around 72%-85% of diabetic patients.The exact mechanism of lipoprotein abnormalities in diabetes is not very well understood. Insulin resistance, rather than hyperglycemia, has been implicated in the pathogenesis of diabetic dyslipidemia because lipoprotein changes including an increase in triglycerides (TG), increase in VLDL particles, small dense LDL particles and a decrease in HDL level have been shown in patients with impaired fasting glucose and impaired glucose tolerance and T2DM
Detailed Description
Hypertriglyceridaemia(HTG) occurs due to both increased production and decreased clearance, and it is the most common abnormality of diabetic dyslipidemia. Insulin resistance causes increased production of VLDL . In addition to increased secretion of VLDL, there is decreased clearance of VLDL due to decreased hepatic uptake and impaired activity of lipoprotein lipase.Management of dyslipidemia in patients with diabetes is an important step in the prevention of cardiovascular disease, the most common cause of death in the diabetic population. Diabetic dyslipidemia treatments can be divided into non-pharmacological and pharmacological. Non-pharmacological treatment includes ; medical nutrition therapy, weight loss, and physical activity. Diabetic patients should increase the intake of plant stanols/sterols, viscous fiber (legumes, citrus, oats), n-3 fatty acids and decrease the intake of saturated and trans-fatty acids. American Diabetes Association recommends the Mediterranean diet or DASH (Dietary Approaches to Stop Hypertension).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemia Associated With Type II Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
diabetic patients type2 with dyslipidemia
Masking
Participant
Allocation
Randomized
Enrollment
190 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group of intervention will receive nutritional program
Arm Type
Active Comparator
Arm Description
group of type 2 diabetes on diabetic diet undergo nutritional program (low fat contents) to control the lipid profile (lowering cholesterol profile) in duration of 3 months.
Arm Title
group of control will not receive nutritional program
Arm Type
No Intervention
Arm Description
group of type 2 diabetes on diabetic drugs without nutritional program to compare their lipid profile with the diabetic patients on nutritional program.
Intervention Type
Other
Intervention Name(s)
DASH diet
Intervention Description
it will be face to face about the role of nutritional program to control dyslipidemia
Primary Outcome Measure Information:
Title
Evaluate the effectiveness of one of the most common dietary approches;DASH diet in controlling lipid profile in diabetic patients.
Description
number of type 2 diabetic patients will undergo nutritional program to control their lipid profile to improve the insulin sensitivity and follow up the result of the diet by investigations (lipid profile) in duration 3 months .
Time Frame
3-6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1-clinical diagosis of type2diabetes 2-clinical diagnosis of hyperlpidemia 3-must be helpful patient 4-age below 70year
Exclusion Criteria:
1-insulin dependant diabetes 2- pregnancy 3-heart disease 4- renal disease. 5-pregnancy
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dalia galal mahran
Phone
01007120821
Email
daliaym2001@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Manal El-sayed Ezz-eldeen
Phone
01005826070
Email
manal_ezeldeen@yahoo.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
31139315
Citation
Jialal I, Singh G. Management of diabetic dyslipidemia: An update. World J Diabetes. 2019 May 15;10(5):280-290. doi: 10.4239/wjd.v10.i5.280.
Results Reference
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PubMed Identifier
9673301
Citation
Haffner SM, Lehto S, Ronnemaa T, Pyorala K, Laakso M. Mortality from coronary heart disease in subjects with type 2 diabetes and in nondiabetic subjects with and without prior myocardial infarction. N Engl J Med. 1998 Jul 23;339(4):229-34. doi: 10.1056/NEJM199807233390404.
Results Reference
background
PubMed Identifier
4337382
Citation
Friedewald WT, Levy RI, Fredrickson DS. Estimation of the concentration of low-density lipoprotein cholesterol in plasma, without use of the preparative ultracentrifuge. Clin Chem. 1972 Jun;18(6):499-502. No abstract available.
Results Reference
background
PubMed Identifier
21772854
Citation
Sharifirad G, Entezari MH, Kamran A, Azadbakht L. The effectiveness of nutritional education on the knowledge of diabetic patients using the health belief model. J Res Med Sci. 2009 Jan;14(1):1-6.
Results Reference
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Effectiveness of Nutritional Program Among Diabetic Patients
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